TIDMSTX
RNS Number : 8549D
Shield Therapeutics PLC
05 February 2018
This announcement contains inside information for the purposes
of Article 7 of Regulation 596/2014.
Shield Therapeutics plc
("Shield" or the "Group")
Shield reports top-line results from pivotal Phase III study of
Feraccru(R) (Ferric Maltol) in the treatment of IDA in patients
with CKD
- Primary efficacy endpoint not achieved
- Tolerability profile of Feraccru reconfirmed
- A review of the full dataset will be conducted to better understand the result
- Feraccru remains commercially available for IBD patients with
IDA through Shield and its commercial partners in Europe and other
ongoing clinical studies will continue
London, UK, 5 February 2018: Shield Therapeutics plc (LSE:STX),
a commercial stage, pharmaceutical company delivering innovative
specialty pharmaceuticals to address patients' unmet medical needs,
with an initial focus on addressing anaemia associated with renal
and gastrointestinal disorders, today announces top-line results
from its AEGIS-CKD pivotal Phase III study of Feraccru. Feraccru is
a novel oral ferric iron therapy that has been approved and
marketed in Europe since 2016 for the treatment of iron deficiency
anemia (IDA), initially in patients with inflammatory bowel disease
(IBD).
The Feraccru AEGIS-CKD study is a pivotal Phase III trial with a
primary endpoint evaluating haemoglobin response to Feraccru
(ferric maltol, 30mg twice daily) compared to placebo in the
treatment of IDA in patients with chronic kidney disease (CKD).
Top-line data is based on the 16-week primary endpoint, with 168
subjects enrolled in 30 renal centres across the US.
Initial clinical trial results:
Feraccru failed to meet the study's primary endpoint of
demonstrating a statistical difference in change of haemoglobin
from baseline compared to placebo at 16 weeks (0.45 v 0.15 g/dL,
p=0.1686).
The response at 8 weeks demonstrated separation of the treatment
arms (0.53 v 0.0 g/dL), which was not sustained to week 16.
Patient drop-out rate was low over 16 weeks and similar in both
arms - 10 (9%) in the Feraccru arm v 7 (12.5%) placebo,
reconfirming the strong tolerability profile of Feraccru.
Carl Sterritt, Chief Executive Officer of Shield Therapeutics,
said: "We are surprised and disappointed by these top-line
findings. Feraccru has previously demonstrated positive efficacy
and safety in IBD patients, which led to it being approved in
Europe where it continues to gain commercial traction. We now await
the full dataset in order to fully understand the study's outcome
and define the next steps in our strategy. Concurrently, we will
focus on interacting with EMA on the label expansion application,
on concluding the AEGIS-H2H study as expeditiously as possible and
on taking actions to extend the current cash runway beyond the end
of Q2 2018."
Other Feraccru pipeline events:
Feraccru AEGIS-H2H non-inferiority EU Phase 3b study
The AEGIS-H2H Phase 3b study is designed as a non-inferiority
trial comparing the efficacy and safety of Feraccru to the
market-leading latest generation form of IV iron
(Ferinject/Injectafer, ferric carboxymaltose). Primary endpoint
data from the AEGIS-H2H study is expected to be available in the
second half of 2018.
Feraccru in Europe - possible extension of commercial label
In September 2017, Shield submitted an application to the
European Medicines Agency, to broaden the existing commercial label
for Feraccru to include the treatment of all patients with IDA,
which has the potential to significantly expand the market
opportunity for Feraccru in Europe. We continue to expect a final
decision from the EMA on this application during the first half of
2018.
Strategy and next steps
Shield will continue to analyse the preliminary data findings
from the AEGIS-CKD pivotal Phase III study and will conduct a
review of the study's full dataset as soon as it is available, to
understand the detailed results and assess whether any other
confounding factors affected the outcome. In parallel, Feraccru
will continue to be available commercially through Shield and our
European partners for IBD patients with IDA. The Group will seek to
provide a further update when it announces its financial results
for the year ended 31 December 2017.
- Ends -
For further information please contact:
Shield Therapeutics plc +44 (0)207 186 8500
Carl Sterritt, Chief Executive Officer
Dr Karl Keegan, Chief Financial Officer
Nominated Advisor and Joint Broker +44 (0)203 100 2222
Liberum Capital Limited
Christopher Britton/Steve Pearce
Joint Broker +44 (0)207 418 8900
Peel Hunt LLP
James Steel/ Dr Christopher Golden
Financial PR Advisor +44 (0)203 709 5700
Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal
US Investor Relations +1 (212) 867 1762
Lazar Partners
Fern Lazar/David Carey
This announcement contains inside information for the purposes
of Article 7 of Regulation 596/2014. The person who arranged for
the release of this announcement on behalf of Shield was Dr Mark
Sampson, Chief Medical Officer
About Feraccru(R)
Feraccru is a novel, stable, non-salt, oral formulation of
ferric iron, which has a differentiated mechanism of action
compared to salt-based oral iron therapies. When salt-based oral
iron therapies are ingested, the iron must dissociate from the salt
in the GI tract to allow the iron to be absorbed and treat the IDA.
This free iron readily chelates to form insoluble clumps and
produces damaging free radicals that together cause a range of
mild-to-severe GI adverse events, including nausea, bloating and
constipation, leading to poor tolerability, reduced patient
compliance and ultimately treatment failure. In addition, many
patients with IDA are concurrently treated with medicines that
raise the pH in the gut which further reduces the effect of
salt-based oral iron therapies as they require highly acidic
conditions to be absorbed. Feraccru is not an iron salt, and iron
can be absorbed from the ferric maltol molecule, as a result, it
does not routinely cause the same treatment-limiting intolerance
issues. Feraccru has been shown in clinical trials to be
well-tolerated by patients even when they had previously failed
treatment with salt-based oral iron therapies, which should lead to
increased patient compliance and better patient outcomes.
Currently, the only treatment option for IDA patients who cannot
tolerate salt-based oral iron therapies, is IV iron therapy. IV
iron therapies quickly increase iron stores via direct
administration of very large doses of iron, causing an increase in
Hb levels that is physiologically controlled and occurs over a
period of weeks, as is the case with Feraccru. IV iron therapies,
however, are invasive, costly, inconvenient and complex to
administer, and also come with potentially life-threatening,
spontaneous hypersensitivity reactions.
About Shield Therapeutics plc
Shield is a commercial stage, pharmaceutical company delivering
innovative specialty pharmaceuticals to address patients' unmet
medical needs. Our clear purpose is to help our patients become
people again, by enabling them to enjoy the things that make the
difference in their everyday lives. The Group has a marketed
product, Feraccru(R), for the treatment of IDA in adult patients
with IBD which has exclusive IP rights until the mid-2030's. For
more information please visit www.shieldtherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements. All
statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements. These forward-looking statements are based on
management's current expectations and include statements related to
the timing of future results of Feraccru trials and the timing and
success of the Group's regulatory plans and commercial strategy for
Feraccru. These statements are neither promises nor guarantees, but
involve known and unknown risks and uncertainties, many of which
are beyond our control, that may cause actual results, performance
or achievements to be materially different from management's
expectations expressed or implied by the forward-looking
statements, including, but not limited to, risks associated with
the regulatory approval process, the Group's business and results
of operations, competition and other market factors. The
forward-looking statements made in this press release represent
management's expectations as of the date of this press release, and
except as required by law, the Group disclaims any obligation to
update any forward-looking statements contained in this release,
even if subsequent events cause our views to change.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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